Kornimate/medical-research-clean huggingface dataset:
a study of an investigational drug, cemdisiran (aln-cc5), in patients with atypical hemolytic uremic syndrome

Conditions: Atypical Hemolytic Uremic Syndrome

Summary: the purpose of this study is to evaluate the safety, tolerability and pharmacokinetics of cemdisiran in patients with ahus.


Eligibility criteria:
inclusion criteria: 1. willing to provide written informed consent and to comply with the study requirements 2. age 18 years or older 3. clinical diagnosis of primary ahus 4. clinical thrombotic microangiopathy (tma) activity 5. women of child-bearing potential must have a negative pregnancy test, cannot be breast feeding, and must be willing to use a highly effective method of contraception 6. previously vaccinated with meningococcal group acwy conjugate vaccine and meningococcal group b vaccine or willingness to receive these vaccinations 7. adamts13 \>10% or other proven ahus-associated mutation exclusion criteria: 1. clinically significant abnormal laboratory results 2. positive shiga toxin producing escherichia coli test at screening 3. suspected secondary ahus, in the opinion of the investigator (unless there is a documented ahus-associated genetic mutation) 4. positive direct coombs test 5. patients who have received hemodialysis for \>3 months 6. bone marrow transplant recipients 7. organ transplant recipients, except for kidney transplant recipients with primary ahus (confirmed by known genetic mutation and kidney biopsy) 8. known history or evidence of systemic lupus erythematosus or antiphospholipid antibody syndrome 9. history of multiple drug allergies or history of allergic reaction to an oligonucleotide or galnac 10. malignancy (except for non-melanoma skin cancers, cervical in-situ carcinoma, breast ductal carcinoma in situ, or stage 1 prostate carcinoma) within the last 5 years 11. patients with a poor prognosis that is expected to limit their life expectancy to less than 3 months, in the opinion of the investigator

Keywords: rnai therapeutic atypical hemolytic uremic syndrome hemolysis thrombocytopenia renal insufficiency thrombotic microangiopathy ahus tma
local paclitaxel or balloon angioplasty below the knee

Conditions: Stenosis; Occlusion; Restenosis

Summary: patients with claudication or critical limb ischemia will be treated either with uncoated balloons or paclitaxel coated balloons in order to enhance the vessel patency in stenosed or occluded below the knee arteries

after successful guide wire passage of the below the knee index lesions the patients will either receive a treatment with a conventional uncoated balloon or a balloon coated with paclitaxel. only patients who require follow-up angiography after 6 months will be included in this study. the primary endpoint (index vessel occluded or still open) is at 6 months - the patients will be also followed for 24 months for clinical endpoints. in addition an mri is planned at 12 months.

Eligibility criteria:
inclusion criteria: * \>18 years of age * chronic stenotic or occlusive atherosclerotic disease of the infrapopliteal arteries * rutherford 2-5 patients * patients with ≤ 2 btk lesions (≥ 70% diameter stenosis) * lesion length limited to 5-25 cm exclusion criteria: * planned or foreseeable amputation * previous amputation at the index limb * index vessel with no run-off to the foot distal to the index lesion * prior treatment of the index lesion with a drug coated balloon * in-stent restenosis * life expectancy \<1 year * known creatinine \>1.4 mg% if patient is not on dialysis * acute thrombus in the index limb * aneurysm in the index leg * known hypersensitivity or contraindication to aspirin, heparin, clopidogrel, abciximab, paclitaxel * patients with concomitant medical illnesses that require cytostatic or radiation therapy

Keywords: below the knee artery endovascular drug coated balloon critical limb ischemia
physical activity to modify sequelae and quality of life in childhood acute lymphoblastic leukemia

Conditions: Acute Lymphoblastic Leukemia

Summary: this will be the first multidisciplinary, randomized, longitudinal trial of a tailored, parent- and child-focused physical activity program for children (ages 4- \<19 years) with newly diagnosed all. it will test the ability of the intervention to prevent or diminish early physical function limitations and improve health-related quality of life (hrql). the intervention will be tested for its effect on: 1) physical function outcomes (muscle strength, range of motion, endurance, gross motor skills), bone density and bone mineral content (end of therapy only); and 2) hrql. this multi-site trial will test the intervention in 76 evaluable children with all (38 receiving the intervention and 38 receiving a placebo "minimal movement" standard care strategy).

an advanced practice nurse (apn) will meet twice weekly with the patient and family for the first 4 weeks of the intervention to initiate the motivation-based dialogue and therapeutic interaction; this will be followed by once weekly visits during weeks 5-8 of the intervention; and monthly visits during weeks 9-through end of therapy. the physical therapist (pt) will meet at least once weekly with the patient and family during weeks 1-4 to initiate the prescriptive tailored exercise program; subsequent visits to reinforce and modify the program will occur at least once every other week during weeks 5-8, and at least once monthly during weeks 9-135 of the intervention. the pt will visit at least once weekly during weeks 1-4, at least once every other week during weeks 5-8, and at least once monthly during weeks 9-135. during weeks 9-135 of the intervention, the apn will call between the monthly in person-visits, if needed to those randomized to the map group to assure fidelity to the intervention and to provide booster support to the intervention where needed.

Eligibility criteria:
inclusion criteria: 1. an immunophenotypic diagnosis of non-b cell all 2. age 4 years through \<19 years at diagnosis 3. 2-8 days on or per front line all treatment protocol 4. one parent or legal guardian (≥ 18 years) of the study subject who speaks and understands the english language 5. participant speaks and understands the english language 6. written informed consent and child assent exclusion criteria: 1. age \< 4 years or ≥19 years at diagnosis 2. a diagnosis of cerebral palsy or down syndrome 3. second malignancy, chromosome breakage syndrome, or severe congenital immunodeficiency 4. inability or unwillingness of research participant or legal guardian/representative to give written informed consent/assent 5. females who are pregnant.
assessment of response rates and yields for two tools for early detection of non-diabetic hyperglycaemia and diabetes

Conditions: Diabetes

Summary: the purpose of this study is to establish the most effective method of increasing attendance to screening of type 2 diabetes within a primary care setting within the backdrop of the nhs health check programme.

the university hospitals of leicester and the university of leicester have developed a self-assessment risk score and a practice data risk score that can be used in a variety of setting to detect undiagnosed diabetes and impaired glucose regulation. this is done to establish a simple and effective 1st stage screen to identify those people at risk of diabetes and engage the public to increase the number of high risk individuals attending screening invitations but reducing the overall number of oral glucose tolerance tests. this study aims to test in a pragmatic way the use of such tools in a primary care setting administered by primary care staff as part of the nhs health check programme.

Eligibility criteria:
inclusion criteria: * 40-75 years old (30 -75 years old if south asian origin) exclusion criteria: * current diagnosis of diabetes * terminal illness or mental incapacity

Keywords: diabetes screening risk self assessment
oncoplastic breast-conserving surgery in non-metastatic breast cancer patients

Conditions: Local Recurrence of Malignant Tumor of Breast

Summary: breast-conserving surgery (bcs) is the traditional surgical treatment for early-stage breast cancer patients. there are evidences indicating that oncoplastic-bcs (displacement technique) could improve cosmetic outcomes and/or quality of life, and has similar oncological safety as traditional bcs does. however, there are no prospective trial comparing oncoplastic-bcs vs. traditional bcs in terms of cosmetic outcomes and oncological safety. in this study, the investigators are going to address this issue by assigning patients into traditional and oncoplastic-bcs group, based on their preference.


Eligibility criteria:
inclusion criteria: * informed consent signed * ecog\<=2 * non-metastatic breast cancer patients with unilateral breast cancer confirmed by pathology. * operable or operable after neoadjuvant chemotherapy. * extensive, diffuse micro-calcifications on mammography before surgery * no history of breast surgery or breast radiation therapy before. * able to follow the standard of care in adjuvant chemotherapy, radiation therapy, endocrine therapy and targeted therapy after surgery. exclusion criteria: * multifocal/multicentric diseases noticed before surgery. * inflammatory breast cancer or invasive micro-papillary carcinoma of the breast confirmed by pathology before surgery. * tumor size \> 5 cm revealed by physical examination, ultrasound or mammography before surgery. * tumor size/breast size ratio \>0.5 revealed by by physical examination, ultrasound or mammography before surgery. * have other malignant tumors. * have severe co-morbidities that compromise the patients' compliance to our protocol, or endanger the patients. * participated in other clinical trials. * pathologically confirmed metastatic breast cancer, bilateral breast cancer or dcis patients. * patients with any organ failure. * pregnancy women * patients who desire to have mastectomy before surgery.

Keywords: morbidity the breast cancer treatment outcome scale disease free survival positivity cavity margin rate harvard/nsabp/rtog breast cosmesis grading scale
the comprehensive assessment in children after surgical treatment of patellar recurrent dislocation.

Conditions: Recurrent Patellar Dislocation; Patellar Instability

Summary: the aim of this prospective study is to assess extension apparatus function of the knee based on clinical, radiological, isokinetic and gait analysis data in patients after surgical treatment. there will be used physical examination, lysholm-tegner and kujala scale for clinical assessment. merchant and lateral x-ray pictures will be analysed for patellar position verification along with isokinetic and gait evaluation to produce conclusions referring to efficacy of the treatment. all subjects included in the study were treated with mpfl reconstruction. follow-up longer than 2 years in all cases, about 45 patients included.

recurrent patellar dislocation occurs mostly in adolescents. recently medial patellofemoral ligament reconstruction has become treatment of choice in most cases. there is still insufficient literature to assess the operative treatment results according to functional testing. the aim of this prospective study is to assess extension apparatus function of the knee based on clinical, radiological, isokinetic and gait analysis data in patients after surgical treatment. there will be used physical examination, lysholm-tegner and kujala scale for clinical assessment. merchant and lateral x-ray pictures will be analysed for patellar position verification along with isokinetic and gait evaluation to produce conclusions referring to efficacy of the treatment. all subjects included in the study were treated with mpfl reconstruction with gracilis tendon harvesting. follow-up provided is longer than 2 years in all 45 cases planned to enroll. all subject are to be mailed and invited to check-up visit including analysis of parameters mentioned above. soon after data collection text of the publication will be made. the results will be discussed with recent literature and conclusions will be made.

Eligibility criteria:
inclusion criteria: * age \<18 yo * recurrent patellar dislocation * ready for follow-up exclusion criteria: * age \<18 yo * osteochondral fracture * habitual dislocation

Keywords: patellar instability recurrent patellar dislocation isokinetics children mpfl reconstruction
comparison of home-based exercise on the posterior canal benign paroxysmal positional vertigo symptoms

Conditions: Benign Paroxysmal Positional Vertigo

Summary: benign paroxysmal positional vertigo (bppv) is the most common vestibular disorder in adults and the treatment of choice is by particle repositioning manoeuvres (prm). this study aims to compare the treatment efficacy of two home-based exercises, self-epley manoeuvre (sem) and brandt-daroff exercise (bde) in patients with posterior canal bppv based on vertigo resolution, reduction of vertigo intensity, the dizziness handicap inventory scores and the conversion of a positive to negative dix-hallpike test.

study objective: to compare the efficacy of the self-epley manoeuvre to the brandt-daroff exercise in resolving vertigo symptoms in patients with unilateral posterior canal bppv. study design: single-blind randomized controlled study sample size: fifty patients were recruited in the study and were divided with 25 patients in each treatment arm. study method: patients who satisfy the inclusion criteria and have given informed consent were randomized into the 2 treatment groups. a dedicated physiotherapist will demonstrate the selected exercise (either sem or bde) and observed the patient performing the exercise twice to ensure the ability of the patient to perform it correctly at home. a diary was provided for the patients to chart the therapy sessions performed at home as well as a pamphlet with simple illustrated instructions of the chosen exercise. the patients were asked to perform the home-based exercise for 2 weeks. primary outcome measure - resolution of vertigo symptoms in patients with unilateral posterior canal bppv. secondary outcome measures * vertigo resolution at 1 and 6 months; * the conversion of positive to negative dix-hallpike test between both groups after 1 month; * vertigo intensity in unresolved vertigo patients at 1 \& 6 months; * the dizziness handicap inventory between both groups at 1 and 6 months.

Eligibility criteria:
inclusion criteria: * patients who have had symptoms of vertigo for at least 1 week duration, * patients with a documented positive dix-hallpike test on referral, * patients with intact cognitive function and had the ability to communicate and understand instructions to perform a home-based exercise. exclusion criteria: * patients with history of prior ear surgery, * patients with orthopaedic or connective tissue disorder that impairs functional neck or trunk range of motion, * patients with a significant neurological disorder or spinal cord damage, and * patients who have been prescribed with home-based exercises for bppv.

Keywords: vertigo benign paroxysmal positional vertigo particle repositioning manoeuvre
depression and anxiety among chronic pain patients in the netherlands

Conditions: Chronic Pain; Depression, Anxiety

Summary: the aim of this study is to examine the prevalence of anxiety and depression among patients with chronic pain attending secondary and tertiary pain clinics in the netherlands. additionally, the study explores how pain intensity, sociodemographic factors, and the presence of anxiety or depression are associated with quality of life in this population. using an anonymized dataset provided by the data manager, we aimed to prevent a low response rate at amsterdam umc and thereby reduce the risk of non-response bias.

chronic pain is defined as pain which exists for a period longer than 3 months. the prevalence of chronic pain in the netherlands is estimated to be 19 percent. chronic pain is a complex disorder which is often challenging to treat. the dynamic interaction between de different aspects of chronic pain, like the somatic, physical and social aspects, make the treatment challenging. patients with chronic pain have a three times increased risk of developing psychiatric symptoms (usually mood and anxiety disorders) and vice versa, patients with depression have a three times increased risk of developing chronic pain. also independently chronic pain and depression are both invalidating disorders, regardless of age and gender. it has been found that there is an increased risk of suicide among patients with chronic pain. the complex interaction between chronic pain and depression and their cumulative effect on the quality of life in the netherlands has not yet been completely identified. this is because the interaction between chronic pain and depression is not yet fully understood. the treatment can be improved when the interaction between pain and depression is better understood. the research acts as a preliminary investigation for the treatment of patients with chronic pain with intrvenous esketamine, a recently approved treatment for treatment resistant depression.

Eligibility criteria:
patients over 18 years old with chronic pain, who have been treated at the pain clinic at amsterdam umc from 2020 to 2024, will be included in the study, provided they have completed the hads questionnaires in full. patients with incomplete hads questionnaires and those who have filed a general objection to the use of their data for this scientific research will be excluded from participation in the analysis.

Keywords: chronic pain depression anxiety
effects of somatostatin on adpkd heart

Conditions: Autosomal Dominant Polycystic Kidney Disease; Glomerular Filtration Rate > 40 ml/Min

Summary: autosomal dominant polycystic kidney disease (adpkd) is associated with early onset hypertension and left ventricular (lv) hypertrophy. since lv hypertrophy is associated with lv diastolic function impairment, we aimed to assess the changes over time of lv diastolic function in adpkd patients and whether they were affected by the treatment with the somatostatin analogue, octreotide. 35 adpkd patients (14 males) aged 34±8 years (mean glomerular filtration rate 82±26 ml/min/1.73m2) were randomly assigned to 36 month treatment with placebo (n=18) or octreotide (n=17). clinical and echocardiography parameters were evaluated at baseline and study end. lv mass (m) and ejection fraction (ef) were calculated according to devereux formula and biplane simpson's algorithm, respectively. lv filling was assessed by mitral and pulmonary vein flow velocity curves and mitral annulus early diastolic velocity peak (ea) by tissue doppler imaging.


Eligibility criteria:
inclusion criteria: * diagnosis of autosomal dominant polycystic kidney disease * glomerular filtration rate grater than 40 ml/min exclusion criteria: * diabetes mellitus * proteinuria greater than 1 g/24 hours * significant glomerular disease * urinary tract lithiasis and infections * symptomatic gallstones * biliary sludge * cancer * pregnant women * lactanting women
trial of antihypertensive intervention management

Conditions: Cardiovascular Diseases; Heart Diseases; Hypertension; Vascular Diseases

Summary: the objective of the trial of antihypertensive intervention management (taim) was to determine the efficacy of dietary management and/or drug therapy, namely thiazide-like diuretics or a beta-blocker, in the control of mild hypertension. additionally, the continuation of the trial of antihypertensive intervention management (cotaim) tested the effects of long-term weight reduction, and sodium/potassium changes added to weight reduction, as well as the original drug treatment, on the failure rate of blood pressure control.

background: the trial of antihypertensive intervention management was an extension of the nhlbi-supported dietary intervention study of hypertension (dish) which concluded in march 1984 and showed that either weight reduction or sodium restriction diets reduced relapse rates of hypertensives who had received long-term drug treatment and then been withdrawn from drugs. taim was initiated in april 1984 and continued for four years at three centers and added to dish the art of evaluating combined drug and dietary treatments. cotaim was continued at three clinical sites in july 1988. analysis of cotaim results continued through november 1994 under grant r01hl40072. design narrative: taim patients were randomly assigned to one of three diets and to one of three drug regimens. the dietary interventions consisted of a weight loss program, sodium reduction with increased potassium intake, or no change in diet. the drug regimen consisted of a beta-blocker (atenolol), a thiazide-like diuretic (chlorthalidone), or placebo. the major endpoint was change in diastolic blood pressure after six months of intervention. individuals who did not reach goal blood pressure after six months received additional drugs. other endpoints included total risk factor score change, psychological function, and lifestyle change. cotaim consisted of two studies with a total of 600 subjects. cotaim i compared the taim weight loss group to a randomly selected half of the usual diet group. the primary endpoint of cotaim i was the degree of control of blood pressure on initial taim therapy between taim baseline and the end of cotaim, a five year period. cotaim ii added a weight loss regimen both to the sodium restriction/potassium supplementation groups and to the other half of the usual diet group. the primary outcome was control of blood pressure on initial taim therapy between cotaim baseline and the end of cotaim, a two-year period.

Eligibility criteria:
men and women, ages 21 to 65, with mild hypertension in the range of 90 to 100 mm hg diastolic blood pressure. subjects were obese (110-150 percent of ideal weight).